Methods for delivery of heart valve devices using intravascular ultrasound imaging

ABSTRACT

Methods related to delivery of various heart valve implants are described. The implant may be delivered using an ultrasound imaging delivery system. The ultrasound imaging delivery system may be used to deliver a variety of different devices, including mitral valve reshaping devices, mitral valve replacement valves, and others. A deployment catheter carrying an implant having a tissue anchor is advanced to a deployment site in a heart. An imaging element is positioned adjacent the implant and a relationship between the tissue anchor and an anatomical landmark in the heart is visualized. The implant is then attached by driving the tissue anchor into tissue in the heart.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57. Forexample, this application claims the benefit of priority under 35 U.S.C.§ 119(e) of U.S. Provisional Application No. 62/234,592 entitled “HEARTVALVE DELIVERY SYSTEM WITH INTRAVASCULAR ULTRASOUND IMAGING CAPABILITY”and filed on Sep. 29, 2015, the entire disclosure of which isincorporated herein by reference for all purposes and forms a part ofthis specification.

BACKGROUND Field

In general, features related to systems and methods of deliveringimplantable medical devices are described. For example, delivery andpositioning systems and methods for implanting various devices in aheart valve, for example to treat cardiac valve insufficiency, aredescribed.

Description of the Related Art

Heart valve incompetency is a serious problem. For example, heartdisease can cause the chambers of the heart to expand and weaken. Withspecific reference to the mitral valve, as a result of aging or disease,the left ventricle dilates and the papillary muscles are displaced.Consequently, the annulus of the mitral heart valve dilates excessively.In this state of dilation, valve leaflets no longer effectively close,or coapt, during systolic contraction. Consequently, regurgitation (i.e.retrograde flow back across the valve that should be closed) of bloodoccurs during ventricular contraction. Cardiac output is thus decreased.

This condition is typically addressed by the surgical implantation of anannuloplasty ring. A surgeon positions the annuloplasty ring proximatethe valve annulus and sutures it in place thereby restoring the valveannulus to approximately its native configuration. The valve leafletscan now function normally again.

This procedure is invasive as it is performed open chest and is alsotime consuming. In open heart surgery, the patient is put oncardiopulmonary bypass with its associated risks of morbidity andmortality due to stroke, thrombosis, heart attack and extended recoverytime.

There is, therefore, a need for less invasive and more efficientsolutions to these problems that avoid the aforementioned drawbacks.

SUMMARY

The embodiments disclosed herein each have several aspects no single oneof which is solely responsible for the disclosure's desirableattributes. Without limiting the scope of this disclosure, its moreprominent features will now be briefly discussed. After considering thisdiscussion, and particularly after reading the section entitled“Detailed Description,” one will understand how the features of theembodiments described herein provide advantages over existing systems,devices and methods.

The following disclosure describes non-limiting examples of someembodiments. For instance, other embodiments of the disclosed systemsand methods may or may not include the features described herein.Moreover, disclosed advantages and benefits can apply only to certainembodiments of the invention and should not be used to limit thedisclosure.

Systems and methods of delivering a heart valve implant using ultrasoundimaging are described. The implant is intended to be delivered in aminimally invasive percutaneous manner, such as transfemorally,transeptally, or transapically. The implant may instead be implantedsurgically, in that it should reduce the duration of the procedure and,more particularly, the duration that the patient is on bypass.Furthermore, it should be recognized that the development can bedirected to mitral valve or tricuspid valve procedures.

The development relates to the implant and delivery systems, andassociated methods of use of each. The implant is a device capable ofextending out to the dilated annulus of a heart valve, engaging thetissue of the heart valve annulus, and gathering or cinching it in to asmaller diameter. The implant includes a tubular frame with moveablestruts, where pairs of adjacent struts form apexes. The apexes havecollars at least partially surrounded the apex. After engaging heartvalve annulus tissue with the implant, the collars can be moved down theapex to decrease the angle between the adjacent struts, causing thetubular frame to contract in width. This pulls the tissue of the heartvalve annulus closer together. In some embodiments, the device has aring-like member formed of a shape memory material that can be expanded,e.g. forcibly expanded, to engage and penetrate the tissue of the heartvalve annulus. When the force is removed, the device moves, e.g. pulls,the tissue of the heart valve annulus tissue closer together. Theimplant thus reconfigures. the valve annulus down to a smaller diameter,reducing and/or eliminating problems associate with the valve, such asregurgitation.

A delivery system and associated methods are also disclosed thatcomprise a catheter and imaging and positioning features to maneuver thedistal end of the catheter and the device into the desired positionabove and proximate the heart valve annulus. Additionally, the cathetercan have modified distal and intermediate sections to facilitate thebending requirements encountered during intravascular or transeptaldelivery of the device. Transeptal delivery may be used, for example,with procedures involving the mitral valve. The delivery system can beused with the implant described herein as well as other implantabledevices.

Moreover, the development also provides an artificial heart valve with amodified ring-like structure that not only provides for reduction of theheart valve annulus, but also displaces one or more defective heartvalve leaflets. The artificial valve may include the various implantdevices described herein having the one or more leaflets attachedthereto.

In one aspect, a method of anchoring an implant in the heart isdescribed. The method comprises advancing a deployment catheter to adeployment site in a heart, the deployment catheter releasably carryingan implant having at least one tissue anchor, positioning an imagingelement in the heart adjacent the implant, visualizing a relationshipbetween the tissue anchor and an anatomical landmark in the heart, andattaching the implant by driving the tissue anchor into tissue in theheart.

In some embodiments, the positioning an imaging element step comprisesadvancing the imaging element transvascularly along a same access pathfollowed by the deployment catheter. In some embodiments, thepositioning an imaging element step comprises advancing the imagingelement through a lumen in the deployment catheter.

In some embodiments, the positioning an imaging element step comprisesadvancing the imaging element transvascularly along an access path thatis different from an access path followed by the deployment catheter.

In some embodiments, the positioning an imaging element step comprisesdirecting the imaging element to a predetermined relationship with thedeployment catheter using an alignment structure. In some embodiments,the imaging element is carried by an imaging catheter and thepositioning step comprises centering the imaging catheter within theimplant using the alignment structure. In some embodiments, thecentering step comprises inclining at least one alignment arm withrespect to a longitudinal axis of the deployment catheter.

In some embodiments, the visualizing step comprises capturing at leastone radial image. In some embodiments, the visualizing step comprisescapturing at least one circumferential image. In some embodiments, thevisualizing step comprises visualizing a heart valve annulus.

In some embodiments, the visualizing step comprises visualizing a Mitralvalve annulus. In some embodiments, the attaching an implant stepcomprises attaching a Mitral valve annulus reshaping device. In someembodiments, the attaching an implant step comprises attaching a Mitralvalve leaflet repair device. In some embodiments, the attaching animplant step comprises attaching a replacement Mitral valve.

In some embodiments, the attaching step comprises driving at least twoanchors into tissue in the heart. In some embodiments, the attachingstep comprises driving at least six anchors into tissue in the heart.

In some embodiments, the attaching step comprises rotating the anchor.

In some embodiments, the method further comprises the step of capturinga circumferential image following the attaching step. In someembodiments, the method further comprises the step of releasing theimplant from the deployment catheter following the capturing acircumferential image step. In some embodiments, the method furthercomprises the step of manipulating at least one anchor following thecapturing a circumferential image step.

In some embodiments, the visualizing step comprises capturing a field ofview that includes at least a portion of the implant and of a Mitralvalve leaflet.

In some embodiments, the deployment catheter has a central longitudinalaxis and further comprising the step of deflecting the imaging elementaway from the central longitudinal axis. In some embodiments, the methodcomprises deflecting the imaging element in the direction of a tissueanchor.

In some embodiments, the method comprises capturing a first image of afirst anchor, repositioning the imaging element, and capturing a secondimage of a second anchor. In some embodiments, the repositioning stepcomprises rotating the imaging element about an axis. In someembodiments, the repositioning step comprises rotating the imagingelement about an axis using a rotational drive mechanism. In someembodiments, the repositioning step comprises manually rotating theimaging element about the axis.

In some embodiments, the imaging element is carried by an imagingcatheter, further comprising locking a proximal engagement structure onthe imaging catheter to a complementary engagement structure on thedeployment catheter.

In another aspect, a method of delivering an implant proximate a cardiacvalve annulus is described. The method comprises advancing a distal endof a delivery catheter proximate the cardiac valve annulus, advancingthe implant through the distal end of the delivery catheter proximatethe cardiac valve annulus, advancing a distal end of an ultrasoundcatheter proximate the cardiac valve annulus, the distal end of theultrasound catheter including one or more ultrasonic transducers,capturing an ultrasound image of the implant and the cardiac valveannulus with the one or more ultrasonic transducers, and anchoring theimplant to the cardiac valve annulus.

In some embodiments, the method further comprises rotating the distalend of the ultrasound catheter proximate the cardiac valve annulus to aplurality of rotational positions; and capturing a series of ultrasoundimages of the implant and the cardiac valve annulus with the one or moreultrasonic transducers at the plurality of rotational positions.

In some embodiments, the one or more ultrasonic transducers includes aradial ultrasonic transducer, and wherein capturing the series ofultrasound images comprises capturing one or more radial images of theimplant and the cardiac valve annulus to properly position anchors ofthe implant for insertion into the cardiac valve annulus. In someembodiments, the one or more ultrasonic transducers includes acircumferential ultrasonic transducer, and wherein capturing the seriesof ultrasound images further comprises capturing one or morecircumferential images of the implant and the cardiac valve annulusbefore anchoring the implant to the cardiac valve annulus. In someembodiments, the one or more ultrasonic transducers includes acircumferential ultrasonic transducer, and wherein capturing the seriesof ultrasound images further comprises capturing one or morecircumferential images of the implant and the cardiac valve annulusafter anchoring the implant to the cardiac valve annulus.

In some embodiments, the method comprises advancing the distal end ofthe delivery catheter proximate the cardiac valve annulus via thefemoral vein or the iliac vein. In some embodiments, the methodcomprises advancing the distal end of the ultrasound catheter proximatethe cardiac valve annulus through the delivery catheter. In someembodiments, the method comprises advancing the distal end of theultrasound catheter proximate the cardiac valve annulus separately fromthe delivery catheter. In some embodiments, the method comprisesadvancing the distal end of the ultrasound catheter proximate thecardiac valve annulus through the aortic valve.

In some embodiments, the ultrasound catheter comprises a proximal endhaving a guidewire entry port, a distal end having a guidewire exitport, and a guidewire extending through the entry and exit ports.

In some embodiments, the ultrasound catheter is an intravascular cardiacechography (ICE) catheter.

In some embodiments, the method comprises centering the ultrasoundcatheter relative to the implant before capturing the ultrasound imageand anchoring the implant. In some embodiments, the method comprises theultrasound catheter is centered relative to the implant by coupling theimplant with the ultrasound catheter via a plurality of radial arms of acentering frame that extend from the implant to the ultrasound catheter.

In some embodiments, the implant comprises a series of struts defining atubular frame and an axis and forming a plurality of upper and lowercrowns, a plurality of anchors coupled with the lower crowns of theframe and configured to translate axially relative to the frame toengage cardiac tissue proximate the cardiac valve annulus, and aplurality of collars at least partially surrounding the upper crowns andconfigured to translate axially relative to the frame to adjust a widthof the implant. In some embodiments, anchoring the implant to thecardiac valve annulus comprises rotating the plurality of anchors intothe cardiac tissue. In some embodiments, the method comprisestranslating the plurality of collars axially relative to the frame todecrease the width of the implant.

In some embodiments, the implant is a cardiac valve replacement andcomprises a series of struts defining a tubular frame and an axis andforming a plurality of lower crowns, a plurality of anchors coupled withthe lower crowns of the frame and configured to translate axiallyrelative to the frame to engage cardiac tissue proximate the cardiacvalve annulus, and a plurality of valve leaflets coupled with the frame.In some embodiments, anchoring the implant to the cardiac valve annuluscomprises rotating the plurality of anchors into the cardiac tissue. Insome embodiments, the implant further comprises a housing coupled withthe frame, and wherein the leaflets are coupled with the frame via thehousing. In some embodiments, the implant further comprises a pluralityof upper crowns defined by the series of struts, and a plurality ofcollars at least partially surrounding the upper crowns and configuredto translate axially relative to the frame to adjust a width of theimplant. In some embodiments, the implant further comprises an atrialflange.

In some embodiments, the cardiac valve annulus is a mitral valveannulus. In some embodiments, the cardiac valve annulus is a tricuspidvalve annulus.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present disclosure will becomemore fully apparent from the following description and appended claims,taken in conjunction with the accompanying drawings. Understanding thatthese drawings depict only several embodiments in accordance with thedisclosure and are not to be considered limiting of its scope, thedisclosure will be described with additional specificity and detailthrough use of the accompanying drawings. In the following detaileddescription, reference is made to the accompanying drawings, which forma part hereof. In the drawings, similar symbols typically identifysimilar components, unless context dictates otherwise. The illustrativeembodiments described in the detailed description, drawings, and claimsare not meant to be limiting. Other embodiments may be utilized, andother changes may be made, without departing from the spirit or scope ofthe subject matter presented here. It will be readily understood thatthe aspects of the present disclosure, as generally described herein,and illustrated in the drawing, can be arranged, substituted, combined,and designed in a wide variety of different configurations, all of whichare explicitly contemplated and make part of this disclosure.

FIGS. 1A through 1E are perspective views of various embodiments ofdelivery catheters having positioning and imaging capabilities anddelivering various embodiments of heart valve implants for resizing thenative valve annulus.

FIG. 2 is a side view of an embodiment of a modified intravascularcardiac echography (ICE) catheter for delivering, e.g. aligning andpositioning, an implant and having a guidewire entering and exiting thecatheter.

FIGS. 3A-3D are perspective views of another embodiment of an ICEcatheter and delivery system for delivering, e.g. aligning andpositioning, an implant and having a circular array of sensors at thetip of the catheter, e.g. for radial and/or circumferential echo views.

FIGS. 4A through 4E are sequential perspective views of an embodiment ofa delivery system with imaging capability showing an embodiment of amethod for the delivery, positioning and anchoring of an embodiment ofan implant for resizing the native valve annulus.

FIGS. 5A-5C are sequential perspective views of an embodiment of adelivery system with imaging capability showing an embodiment of amethod for the delivery, positioning and anchoring of an embodiment of areplacement heart valve implant.

FIGS. 6A and 6B are side views of an embodiment of a steerable cathetershown in straight and flexed states, respectively, that may be used inthe various systems and methods described herein.

FIGS. 7A and 7B are side views of an embodiment of a distal section of asteerable catheter having a spine that may be used in the varioussystems and methods described herein.

FIGS. 8A and 8B are side views of another embodiment of a distal sectionof a steerable catheter having a thin film that may be used in thevarious systems and methods described herein.

FIG. 9 is a side view of another embodiment of a distal section of asteerable catheter having nesting elements that may be used in thevarious systems and methods described herein.

DETAILED DESCRIPTION

The following detailed description is directed to certain specificembodiments of the development. In this description, reference is madeto the drawings wherein like parts or steps may be designated with likenumerals throughout for clarity. Reference in this specification to “oneembodiment,” “an embodiment,” or “in some embodiments” means that aparticular feature, structure, or characteristic described in connectionwith the embodiment is included in at least one embodiment of theinvention. The appearances of the phrases “one embodiment,” “anembodiment,” or “in some embodiments” in various places in thespecification are not necessarily all referring to the same embodiment,nor are separate or alternative embodiments necessarily mutuallyexclusive of other embodiments. Moreover, various features are describedwhich may be exhibited by some embodiments and not by others. Similarly,various requirements are described which may be requirements for someembodiments but may not be requirements for other embodiments.

Various heart valve implants may be delivered proximate to, above and/oror within, the cardiac valve annulus. Unless otherwise stated, “valve”as used herein may refer to either the tricuspid or mitral valve of theheart. The implant may be subsequently implanted in the annular cardiactissue just above the plane of the valve orifice. In some embodiments,the implant may be a heart valve replacement including valve leaflets,which can be implanted in annular cardiac tissue and extend into thevalve annulus.

Particular features for various embodiments of an implant, of a deliverysystem, and of related systems and methods of use of the delivery system(either together or separately), are described herein. The implant,delivery system, and related systems and methods of use may have thesame or similar features and/or functionalities as other implants,delivery systems, and related systems and methods of use as described,for example, in U.S. patent application Ser. No. 14/861,877 entitled“ADJUSTABLE ENDOLUMENAL IMPLANT FOR RESHAPING MITRAL VALVE ANNULUS andfiled on Sep. 22, 2015, and as described, for example, in U.S.Provisional Application No. 62/234,592 entitled “HEART VALVE DELIVERYSYSTEM WITH INTRAVASCULAR ULTRASOUND IMAGING CAPABILITY” and filed onSep. 29, 2015, the entire disclosure of each of which is incorporatedherein by reference for all purposes and forms a part of thisspecification. Thus, the description of particular features andfunctionalities herein is not meant to exclude other features andfunctionalities, such as those described in the references incorporatedherein by reference or others within the scope of the development.

FIGS. 1A and 1B are perspective views of an embodiment of a distal endof a delivery catheter 40 that may be used to deliver various implants.The delivery catheter 40 has various positioning and imagingcapabilities. The distal end of the delivery catheter 40 is maneuveredinto position above the heart valve annulus. An implant 1A shown beingdelivered in FIGS. 1A-1B is for resizing the heart valve annulus. It isunderstood that a variety of different implants may be delivered withthe delivery system and methods described herein. As shown, thisparticular implant includes a frame 250. The frame 250 has anchors 20attached to a lower or distal portion of the frame 250 and extendingdistally therefrom. The frame 250 has an upper or proximal portion withcollars 252 extending over upper crowns 251 of the frame 250. Only someof the collars 252, upper crowns 251 and anchors 20 are labelled forclarity. The collars 252 may be moved, e.g. distally, along the frame250 by driver tubes 260 to resize the frame 250.

The frame 250, driver tubes 260, and an intravascular cardiac echography(or “ICE”) catheter 270 may be extended from the distal end of thedelivery catheter 40. The drive tubes 260 are shown engagingcorresponding upper crowns 252 of the frame 250. A centering frame 280maintains concentric positioning of the ICE catheter 270 relative to theframe 250 during deployment, alignment and positioning of the frame 250above and proximate to the target heart valve annulus tissue. Thecentering frame 280 maintains a generally centered position of thecatheter 270 relative to the frame 250. By centering the ICE catheterwithin the frame 250, the operator need only rotate the ICE catheter 270to view each anchor 20 and placement of the anchors 20. Further, the ICEcatheter 270 could be used to view various other individual features ofthe implant 1A, such as the collars 252, for instance to view the extentto which each collar 252 is advanced down and over upper crowns 251 ofthe frame 250, to more precisely adjust the size of the frame 250. TheICE catheter 270 could also provide significant benefit to an embodimentwhere a singular cinching mechanism or driver tube needs to be landed oneach crown 251 of the frame 250 to adjust the sizing of the frame 250.An indexing feature (not shown) may also be provided on the ICE catheter270, for example, such that actuation of the indexing feature by theoperator causes the ICE catheter 270 to automatically move, or rotate,to the next anchor 20 position.

FIGS. 1C and 1D are perspective views of an embodiment of an implant 1Bbeing delivered and implanted by the delivery catheter 40. The implant1B may be analogous to the implant 1A. By “analogous” it is meant thetwo features may have the same or similar features and/orfunctionalities. As shown in FIGS. 1C and 1D, the implant 1B includes aframe 10 with struts 12 forming upper apexes or crowns 14 and lowerapexes or crowns 16. The lower crowns 16 have openings 18, such asholes, aligned to receive the anchors 20 there through. For clarity,only some of the upper crowns 14, lower crowns 16, struts 12 and anchors20 are labelled in FIGS. 1C and 1D. The anchors 20 may be rotated tomove distally through the openings 18. The implant 1B is intended to bedelivered proximate to and above a cardiac valve (tricuspid, mitral)annulus, and subsequently implanted in the annular cardiac tissue justabove the plane of the valve orifice.

Driver tubes 22, having proximal portions 22′ extending out of thedelivery catheter 40, are provided for rotationally engaging the anchors20. Manipulation, for example rotation, of the driver tubes 22 by theoperator causes the anchors 20 to advance towards, engage with andpenetrate cardiac tissue to secure frame 10 into the annulus approximateand above the valve. The anchors 20 may be advanced individually one ata time, some advanced together, or all advanced together. In someembodiments, the driver tube 22 may rotate relative to the proximalportion 22′. In some embodiments, the driver tube 22 and proximalportion 22′ are part of the same, continuous driver tube and/or theentire tube 22 and 22′ may rotate together.

An embodiment of an ultrasound catheter 30, such as the Acuson IPX8AcuNav catheter, is shown contained within and advanced down a centrallumen of the delivery catheter 40. The ultrasound catheter 30 may beanalogous to the ICE catheter 270. In some embodiments, by rotating theultrasound catheter 30 around the inside of the valve annulus, therelative position of the frame 10, and of any valve leaflets, will beseen for accurate positioning of the anchors 20 around and above thevalve annulus.

In some embodiments, the ultrasound catheter 30 is contained within andadvanced down an offset, non-central lumen of the delivery catheter 40.In this manner, the ultrasound catheter 30 would not interfere with theframe 10, its attachments or other features, and the driver components.In some embodiments, the ultrasound catheter 30 may be located andsteered to the side of the annulus to image, allowing for less rotationto more quickly view the anchor points of the frame 10. An offset lumencould exit more proximally with regard to the distal end of the deliverycatheter 40. This more proximal exit would reduce the overall profile ordiameter of the distal end of the delivery catheter 40. In addition,this more proximal exit port would enable a view of the valve annulusfrom above. The offset lumen could also be compressible allowing for aneven smaller profile until the ultrasound catheter 40 is advancedthrough the offset lumen.

While the ultrasound catheter 30 is shown integrated into the samedelivery system as the delivery catheter 40, in some embodiments theultrasound catheter 30 could otherwise be introduced secondarily throughanother entry site, such as through the aortic valve, and placed near orinside the implant for imaging and placement of the anchors 20.

FIG. 1E is a perspective view of an embodiment of a centering frame 32coupled to the ultrasound catheter 30 and to an implant 1C. The implant1C may be analogous the implants 1A and 1B. The centering frame 32 hascentering arms 34 connected to a centering hub 36 that is mounted on theultrasound catheter 30. As the distal end of the delivery catheter 40 ismaneuvered into position above the heart valve annulus, the centeringframe 32 maintains concentric positioning of the ultrasound catheter 30relative to the frame 10 during deployment, alignment and positioning ofthe frame 10 above and proximate to the target heart valve annulustissue. The centering aspect is desirable, for example, because if theultrasound catheter 30 remains centered within the frame 10, theoperator such as a surgeon or technician need only rotate the ultrasoundcatheter 30 to view each anchor 20 and placement the of each anchor 20.There may also be an indexing feature (not shown) on the ultrasoundcatheter 30 such that actuation of the indexing feature by the operatorcauses the ultrasound catheter 30 to automatically move, or rotate, tothe next anchor position. The centering frame 32 maybe used withdelivery of the various implants described herein, such as the annulusresizing implants and/or the heart valve replacement implants.

FIG. 2 is a side view of an embodiment of the ICE catheter 270. The ICEcatheter 270 as shown includes a guidewire entry port 292 and aguidewire exit port 294 which together accept the guidewire 296. Thisembodiment allows the ICE catheter 270 to be delivered separately fromthe frame 10 thereby reducing the overall diameter of the deliverycatheter 40 (e.g. as shown in FIGS. 1A and 1B). An ICE handle may belocated at a proximal end of the catheter 270. An ICE array may belocated at the distal end of the catheter 270.

In some embodiments, a separately delivered ultrasound catheter 270could be functionally linked to the distal end of the delivery catheter40 and to the inside of the frame 10. The delivery catheter 40 couldhave mechanical docking and radiopaque features to aid in delivery andstability of the ultrasound catheter 270 relative to the deliverycatheter 40.

FIGS. 3A, 3B, 3C and 3D depict an embodiment of an ICE catheter 300 thatmay be used with the various implant and delivery devices, systems andmethods described herein. The ICE catheter 300 has radial ultrasonictransducers 302, circumferential ultrasonic transducers 304 andguidewire 306 passing centrally therethrough. In some embodiments, theremay be one or more radial ultrasonic transducer and/or one or morecircumferential ultrasonic transducers. A guidewire lumen 303 extendsout from a delivery catheter 240. The delivery catheter 240 may beanalogous to the delivery catheter 40. The ICE catheter 300 extends outthrough the guidewire lumen 303. FIGS. 3B and 3C show an implant 1deployed with the ICE catheter 300 tip. The implant 1 may be analogousto the implants 1A, 1B or 1C. FIG. 3C further shows the relationship ofthe ICE catheter 300 to the delivery catheter 240 while it is taking aradial echo view to properly position the anchor 20 for insertion intoheart valve annulus tissue. FIG. 3D shows the ICE catheter 300 capturinga circumferential echo image for properly positioning the frame 10 in aplane above the heart valve and its leaflets. The features shown anddescribed in FIGS. 3A-3D may be used to deliver various other implants,such as other resizing devices or heart valve replacement valves.

In some embodiments, software or electronic controls can be effective tocycle through the radial cross sectional images around the valve annulusperimeter, relieving the need to physically move, via rotation,translation or deflection, the ICE catheter 300. A largercircumferential transducer array could also be placed distal of theannulus to not interfere with space limitations of the delivery catheter240, further decreasing the profile of the delivery catheter 240. Inanother embodiment, the transducers of the ICE catheter 300 couldgenerate a three dimensional image of the annulus of frame 10. The usercould then more readily see the relative alignment of the annulus, valveleaflets and the implant 1.

The implant 1 or other implants may be delivered, positioned andanchored to reshape the valve annulus or replace the entire valve.Particular embodiments of delivery methods are described in detailherein with reference to the figures.

Generally, the method includes advancing a deployment catheter, such asthe delivery catheters described herein, to a deployment site in aheart, with the deployment catheter releasably carrying the implant,such as the implant 1 or other implants including heart valvereplacements having valve leaflets. The implant has at least one tissueanchor, such as the anchors described herein. An imaging element, suchas the ICE or ultrasound catheters described herein, is positioned inthe heart adjacent the implant. A relationship is visualized between thetissue anchor and an anatomical landmark in the heart, and the implantis attached by driving the tissue anchor into tissue in the heart.

In some embodiments, the method generally includes advancing a distalend of a delivery catheter, such as the delivery catheters describedherein, proximate the cardiac valve annulus in the heart. The implant,such as the implant 1 or other implants including heart valvereplacements having valve leaflets or Mitral valve leaflet repairdevices, is advanced through the distal end of the delivery catheterproximate the cardiac valve annulus. A distal end of an ultrasoundcatheter, such as the ICE or other ultrasound catheters describedherein, is advanced proximate the cardiac valve annulus. The distal endof the ultrasound catheter includes one or more ultrasonic transducers.An ultrasound image is captured, the image being of the implant and thecardiac valve annulus, and captured with the one or more ultrasonictransducers, and the implant is anchored to the cardiac valve annulus.The images may be used to verify the position of, and/or re-position,the anchors before driving the anchors into the cardiac tissue.

These are general descriptions of some embodiments of methods that maybe performed. Particular embodiments of delivering an annulus re-sizingimplant are described with respect to FIGS. 4A-4E, and of delivering aheart valve replacement implant are described with respect to FIGS.5A-5C.

As shown in FIG. 4A, the implant 1 may be inserted into the heart usinga delivery system 401. The implant 1 may be inserted using the deliverysystem 401 via access to the vasculature of the leg, in particular thefemoral vein or the iliac vein. The system 401 may include the variousimplants, catheters and other features described herein, for example theimplant 1, a deployment catheter such as the delivery catheter 240, animaging element such as the ICE catheter 300 and/or transducers thereon,the guidewire 306, etc. The system 401 may include any of the implantsdescribed herein, for example implants including valve annulus reshapingdevices or valve replacements that include valve leaflets. The system401 is then advanced across the septum separating the upper chambers ofthe heart.

As shown in FIG. 4B, the imaging element such as the ICE catheter 300 isadvanced to a position above the heart valve annulus, for example, themitral valve annulus. FIG. 4C shows the implant 1 expelled, i.e.deployed, from the distal end of the delivery catheter 240 above andproximate to the mitral valve annulus. In some embodiments, the implant1 may be deployed before the ICE catheter 300.

The ICE catheter 300 may be positioned by advancing the ICE catheter 300transvascularly along a same access path followed by the deliverycatheter 240. The ICE catheter 300 may be positioned by advancing theICE catheter 300 through a lumen in the delivery catheter 240. In someembodiments, the ICE catheter 300 may be positioned by advancing the ICEcatheter 300 transvascularly along a different path than that followedby the delivery catheter 240. As further shown in FIG. 4B, the guidewire306 may extend through the annulus and into the left ventricle.

In some embodiments, the delivery system 401 may be used to treat thetricuspid valve. For example, the delivery system 401 may be insertedfor access through the jugular vein whereby the system 401 is thenadvanced down the superior vena cava and into the right atrium proximateand above the tricuspid valve annulus.

In some embodiments, the ICE catheter 300 is positioned by directing theICE catheter 300 to a predetermined relationship with the deploymentcatheter 240 using an alignment structure, such as the centering frame32 or 280. In some embodiments, the ICE catheter 300 is centered withinthe implant 1 using the alignment structure. In some embodiments, analignment arm, such as the radial centering arm 34, of the alignmentstructure is inclined with respect to a longitudinal axis of thedeployment catheter 240.

In some embodiments, the deployment catheter has a central longitudinalaxis and the ICE catheter 300, for example the distal end and/or atransducer thereon, is deflected away from the central longitudinalaxis. In some embodiments, the method comprises deflecting the ICEcatheter 300 in the direction of one or more of the tissue anchors 20.In some embodiments, a first image of a first anchor 20 is captured, theICE catheter 300 or portion thereof is then repositioned, and then asecond image of a second anchor 20 is captured. In some embodiments, therepositioning step comprises rotating the ICE catheter 300 about anaxis. In some embodiments, the repositioning step comprises rotating theICE catheter 300 about an axis using a rotational drive mechanism. Insome embodiments, the repositioning step comprises manually rotating theICE catheter 300 about the axis. In some embodiments, the ICE catheter300 carries the imaging element such as a transducer, and the imagingelement is rotated, deflected, etc. as described. In some embodiments, aproximal engagement structure on the ICE catheter 300 is locked to acomplementary engagement structure on the delivery catheter 240.

As shown in FIG. 4D, at least one radial image is taken with the ICEcatheter 300. A series of radial images may be taken. The radial imagesare used to properly position the anchors 20 for insertion into themitral valve annulus tissue. The anchors 20 may be confirmed to be inthe proper position, orientation, etc. and driven into the cardiactissue, for example by rotating the anchors 20. In some embodiments, theimplant is attached by driving at least two anchors into tissue in theheart. In some embodiments, the implant is attached by driving at leastsix anchors into tissue in the heart. In some embodiments, the implantis attached by driving at least eight anchors into tissue in the heart.Other amounts of the anchors may be used as well.

In some embodiments, the distal end of the ICE catheter 300 is rotatedproximate the cardiac valve annulus to a plurality of rotationalpositions, and a series of ultrasound images are captured of the implant1 and the cardiac valve annulus at the plurality of rotationalpositions.

As shown in FIG. 4E, a circumferential image is captured. In someembodiments, multiple circumferential images may be taken. Thecircumferential image is taken after the one or more radial images. Insome embodiments, the circumferential image may be taken prior to theradial imaging. The circumferential image may be used to confirm thatall anchors 20 are appropriately placed and anchored in the mitral valveannulus tissue above the mitral valve leaflets. If one or more anchors20 are not positioned or anchored properly, they can be manipulated, forexample rotationally retracted, repositioned and re-anchored, prior toremoval of the driver tubes. In addition, a circumferential image can betaken prior to anchoring to confirm location of the lower crowns 16 ofthe frame 10 of the implant 1. The radial and/or circumferential imagesmay be used to visualize various anatomical features of the heart, suchas the heart valve annulus, the heart valve, valve leaflets, the Mitralvalve, the Tricuspid valve, and/or other features. In addition oralternatively, the radial and/or circumferential images may be used tovisualize various features of the delivery system 401, such as theimplant 1, the anchors 20, etc. The implant 1 may be released from thedelivery catheter 240 following capturing the circumferential image.

FIGS. 5A-5C are sequential perspective views of an embodiment of adelivery system with imaging capability showing an embodiment of amethod for the delivery, positioning and anchoring of an artificial orreplacement heart valve 700. The methods described with respect to FIGS.5A-5C of delivering the replacement heart valve 700 may incorporate anyof the features of the delivery method described with respect to FIGS.4A-4E regarding delivery of the implant 1.

FIGS. 5A-5C show an ultrasound catheter 600 having a guidewire 660 usedto guide or assist in the delivery and positioning of the replacementheart valve 700. The replacement heart valve 700 may be a variety ofsuitable heart Mitral or Tricuspid heart valve replacements, such as theEdwards Lifesciences Fortis or the Medtronic Twelve transcatheter mitralvalve. In some embodiments, the replacement heart valve 700 with valveleaflets may be delivered with the various ultrasound systems describedherein. The delivery system is inserted via access to the vasculature ofthe leg, in particular the femoral vein or the iliac vein. The system isthen advanced across the atrial-septal wall separating the upperchambers of the heart, as shown in FIG. 5A. The ultrasound catheter 600is advanced to a position above the heart valve annulus, or morespecifically, the mitral valve annulus, as shown in FIG. 5B. FIG. 5Cshows the valve 700 expelled from the delivery catheter across themitral valve, excluding and replacing the function of the native valve.The method shown in FIGS. 5A-5C may incorporate other features describedherein, such as those described with respect to FIGS. 4A-4E, for examplethe various imaging features, various other implants, other accesspoints to the heart, etc.

Relatively large diameter catheter shafts are described herein that maybe used to deliver the ring-like implants, such as the implant 1, orvalve replacements, such as the valve 700, described herein. These largediameter catheter shafts may include features that mitigate or eliminatethe tendency to kink, wrinkle or tear when attempting a sharp bendradius. FIGS. 6A through 9 show various embodiments of sections ofsteerable catheters that improve the catheter's ability to maneuvertight bends to a position above and proximate and/or into the mitralvalve annulus or tricuspid valve annulus.

FIGS. 6A and 6B show a steerable catheter 602 in somewhat straight andflexed states, respectively. The steerable catheter 602 may be used inthe various delivery systems and methods described herein. The steerablecatheter 602 has a distal section 604 and intermediate section 606. Theintermediate section 606 may take the form of a shaft section reinforcedwith a braid or slotted tubing.

FIGS. 7A and 7B depict an embodiment of the distal section 604 that maybe used with the steerable catheter 602, shown in straight and flexedstates, respectively. The distal section 604 has a single spine 608running along its outer curve, and a series of support ribs 610 formedor cut into the inner curve. The distal section 604 may be formed of aflexible metal tube, such as nitinol. The distal section 604 mayincorporate pull wires for control of the delivery system.Alternatively, the pull wire may be looped around the distal section'sdistal tip and back toward the proximal part of the catheter 602. Thesupport ribs 610, with voids therebetween, allow the distal section 604to achieve a tight bend radius. This flexed state of the distal section604 is realized with minimal protrusion of the support ribs 610 into theinner diameter or outer diameter of the distal section 604. Moreover,the spine 608 provides a smooth surface on the outer curve of the distalsection 604 minimizing friction or interference with heart tissue duringdelivery and positioning of the catheter and implant.

FIGS. 8A and 8B illustrate another embodiment of a distal section 614that may be used with the steerable catheter 602. Here, the distalsection 614 may be a flexible metal tube that is wrapped or encased in athin film 612 or polymeric material such as Teflon, pTfe, nylon or otherthin material. This thin film 612 encapsulation does not restrict theflexibility of the distal section 614 but does provide for smootherdelivery and transition into and out of a guide catheter. The thin film612 may be stretchable or designed to fold in on itself, somewhatsimilar to an accordion, when flexed as shown in FIG. 8B.

FIG. 9 shows another embodiment of a distal section 624 that may be usedwith the steerable catheter 602. Here, distal section 624 comprises aseries of larger elements 626 and smaller elements 628. The smallerelements 628 nest within the larger elements 626. All elements may slideover one another. When the distal section 624 is in a straight state,the metal elements are most overlapped. As the distal section 624 isactuated towards the flexed state, as shown for example in FIG. 9, theremay be progressively less overlap of the elements particularly on theouter curve of the distal section 624.

The embodiments of the distal and intermediate sections of the catheter602 are intended for use in the delivery and implant of both thering-like embodiments and the replacement valve embodiments describedherein. In treating the mitral valve, for example, once the catheter ispassed through the septum separating the right and left atria, it isguided slightly upwardly towards the upper reaches of the left atrialchamber. It is then bent significantly in a direction downward towardsthe mitral annulus, aligning the distal end and the implant with themitral annulus. The devices, systems and methods described herein allowsuch bending to occur without kinking or wrinkling which would otherwiseimpede delivery of the implant.

Various modifications to the implementations described in thisdisclosure will be readily apparent to those skilled in the art, and thegeneric principles defined herein can be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. Thus, the disclosure is not intended to be limited to theimplementations shown herein, but is to be accorded the widest scopeconsistent with the claims, the principles and the novel featuresdisclosed herein. The word “example” is used exclusively herein to mean“serving as an example, instance, or illustration.” Any implementationdescribed herein as “example” is not necessarily to be construed aspreferred or advantageous over other implementations, unless otherwisestated.

Certain features that are described in this specification in the contextof separate implementations also can be implemented in combination in asingle implementation. Conversely, various features that are describedin the context of a single implementation also can be implemented inmultiple implementations separately or in any suitable sub-combination.Moreover, although features can be described above as acting in certaincombinations and even initially claimed as such, one or more featuresfrom a claimed combination can in some cases be excised from thecombination, and the claimed combination can be directed to asub-combination or variation of a sub-combination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Additionally, other implementations are within the scope of thefollowing claims. In some cases, the actions recited in the claims canbe performed in a different order and still achieve desirable results.

It will be understood by those within the art that, in general, termsused herein are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

What is claimed is:
 1. A method of anchoring an implant having areplacement mitral valve in the heart, comprising: advancing adeployment catheter to a deployment site in a heart, the deploymentcatheter releasably carrying the implant having at least one tissueanchor; positioning an imaging element in the heart adjacent theimplant; visualizing a relationship between the tissue anchor and amitral valve annulus; and attaching the replacement mitral valve bydriving the tissue anchor into tissue in the heart wherein the imagingelement is carried by an imaging catheter, and the positioning stepcomprises centering the imaging catheter within the implant.
 2. Themethod of claim 1, wherein the positioning an imaging element stepcomprises advancing the imaging element transvascularly along a sameaccess path followed by the deployment catheter.
 3. The method of claim1, wherein the positioning an imaging element step comprises advancingthe imaging element transvascularly along an access path that isdifferent from an access path followed by the deployment catheter. 4.The method of claim 1, wherein the positioning an imaging element stepcomprises directing the imaging element to a predetermined relationshipwith the deployment catheter using an alignment structure.
 5. The methodof claim 4, wherein the positioning step comprises centering the imagingcatheter within the implant using the alignment structure.
 6. The methodof claim 5, wherein the centering step comprises inclining at least onealignment arm with respect to a longitudinal axis of the deploymentcatheter.
 7. The method of claim 1, wherein the visualizing stepcomprises capturing at least one radial image.
 8. The method of claim 1,wherein the visualizing step comprises capturing at least onecircumferential image.
 9. The method of claim 1, wherein the attachingthe replacement mitral valve step comprises driving at least two anchorsinto tissue in the heart.
 10. The method of claim 9, further comprisingthe step of capturing a circumferential image following the attachingstep.
 11. The method of claim 10, further comprising the step ofreleasing the implant from the deployment catheter following thecapturing a circumferential image step.
 12. The method of claim 10,further comprising the step of manipulating at least one anchorfollowing the capturing a circumferential image step.
 13. The method ofclaim 9, comprising capturing a first image of a first anchor,repositioning the imaging element, and capturing a second image of asecond anchor.
 14. The method of claim 1, wherein the attaching stepcomprises rotating the anchor.
 15. The method of claim 1, wherein thedeployment catheter has a central longitudinal axis and furthercomprising the step of deflecting the imaging element away from thecentral longitudinal axis.
 16. A method of delivering an implantproximate a cardiac valve annulus, the method comprising: advancing adistal end of a delivery catheter proximate the cardiac valve annulus;advancing the implant through the distal end of the delivery catheterproximate the cardiac valve annulus; advancing a distal end of anultrasound catheter proximate the cardiac valve annulus, the distal endof the ultrasound catheter including one or more ultrasonic transducers;capturing an ultrasound image of the implant and the cardiac valveannulus with the one or more ultrasonic transducers; and anchoring theimplant to the cardiac valve annulus, wherein the implant comprises: aseries of struts defining a tubular frame and an axis and forming aplurality of upper and lower crowns; a plurality of anchors coupled withthe lower crowns of the frame and configured to translate axiallyrelative to the frame to engage cardiac tissue proximate the cardiacvalve annulus; and a plurality of collars at least partially surroundingthe upper crowns and configured to translate axially relative to theframe to adjust a width of the implant.
 17. The method of claim 16,further comprising: rotating the distal end of the ultrasound catheterproximate the cardiac valve annulus to a plurality of rotationalpositions; and capturing a series of ultrasound images of the implantand the cardiac valve annulus with the one or more ultrasonictransducers at the plurality of rotational positions.
 18. The method ofclaim 16, wherein the one or more ultrasonic transducers includes aradial ultrasonic transducer, and wherein capturing the series ofultrasound images comprises capturing one or more radial images of theimplant and the cardiac valve annulus to properly position anchors ofthe implant for insertion into the cardiac valve annulus.
 19. The methodof claim 18, wherein the one or more ultrasonic transducers includes acircumferential ultrasonic transducer, and wherein capturing the seriesof ultrasound images further comprises capturing one or morecircumferential images of the implant and the cardiac valve annulus. 20.The method of claim 16, comprising advancing the distal end of theultrasound catheter proximate the cardiac valve annulus separately fromthe delivery catheter.
 21. The method of claim 20, comprising advancingthe distal end of the ultrasound catheter proximate the cardiac valveannulus through the aortic valve.
 22. The method of claim 20, whereinthe ultrasound catheter comprises: a proximal end having a guidewireentry port; a distal end having a guidewire exit port; and a guidewireextending through the entry and exit ports.
 23. The method of claim 16,further comprising centering the ultrasound catheter relative to theimplant before capturing the ultrasound image and anchoring the implant.24. A method of delivering an implant proximate a cardiac valve annulus,the method comprising: advancing a distal end of a delivery catheterproximate the cardiac valve annulus; advancing the implant through thedistal end of the delivery catheter proximate the cardiac valve annulus;advancing a distal end of an ultrasound catheter proximate the cardiacvalve annulus, the distal end of the ultrasound catheter including oneor more ultrasonic transducers; capturing an ultrasound image of theimplant and the cardiac valve annulus with the one or more ultrasonictransducers; and anchoring the implant to the cardiac valve annulus,wherein the implant is a cardiac valve replacement and comprises: aseries of struts defining a tubular frame and an axis and forming aplurality of lower crowns; a plurality of anchors coupled with the lowercrowns of the frame and configured to translate axially relative to theframe to engage cardiac tissue proximate the cardiac valve annulus; anda plurality of valve leaflets coupled with the frame.
 25. The method ofclaim 24, further comprising: rotating the distal end of the ultrasoundcatheter proximate the cardiac valve annulus to a plurality ofrotational positions; and capturing a series of ultrasound images of theimplant and the cardiac valve annulus with the one or more ultrasonictransducers at the plurality of rotational positions.
 26. The method ofclaim 24, wherein the one or more ultrasonic transducers includes aradial ultrasonic transducer, and wherein capturing the series ofultrasound images comprises capturing one or more radial images of theimplant and the cardiac valve annulus to properly position anchors ofthe implant for insertion into the cardiac valve annulus.
 27. The methodof claim 26, wherein the one or more ultrasonic transducers includes acircumferential ultrasonic transducer, and wherein capturing the seriesof ultrasound images further comprises capturing one or morecircumferential images of the implant and the cardiac valve annulus. 28.The method of claim 24, comprising advancing the distal end of theultrasound catheter proximate the cardiac valve annulus separately fromthe delivery catheter.
 29. The method of claim 28, comprising advancingthe distal end of the ultrasound catheter proximate the cardiac valveannulus through the aortic valve.
 30. The method of claim 28, whereinthe ultrasound catheter comprises: a proximal end having a guidewireentry port; a distal end having a guidewire exit port; and a guidewireextending through the entry and exit ports.
 31. The method of claim 24,further comprising centering the ultrasound catheter relative to theimplant before capturing the ultrasound image and anchoring the implant.